‘$500 Million in Fines, Forfeitures, and Penalties – The Most Ever Levied against a Generic-Drug Company’

As the Ranbaxy story makes vividly clear, generic-drug makers intent on breaking the rules — especially those operating abroad — can easily do so. Drug applications work on the honor system: The FDA relies on data provided by the companies themselves. “We depend on that information to be truthful,” Gary Buehler, who headed the FDA’s office of generic drugs for 10 years, said in December 2009. (Buehler has since taken a position at the U.S. unit of the Israeli generic-drug company Teva.) The approval system “requires the ethical behavior of the applicant,” he said. Otherwise, “the whole house of cards will fall down.”